Colombia · Spanish · INVIMA
INVIMA translation, aligned to Colombian regulatory practice.
What Colombia's INVIMA expects from Spanish clinical trial and registration documentation — and how an Amavita pilot delivers a package that clears first-cycle review without avoidable requerimientos.
What this covers
INVIMA in three moving parts.
What must be in Colombian Spanish
Protocol, informed consent, investigator's brochure, safety narratives, IFUs, and labeling — using Colombian medical usage rather than neutral or Peninsular Spanish.
Certification and legalization
Legal instruments filed with INVIMA require an official translation by a traductor oficial recognized by the Ministerio de Relaciones Exteriores; apostille and consular legalization rules apply to foreign-origin documents.
Where submissions stall
Inconsistent INN usage, dosing rendered literally from English, and missing appendix translations trigger requerimientos and restart the review clock.
What must be in Colombian Spanish
Protocol, informed consent, investigator's brochure, safety narratives, IFUs, and labeling — using Colombian medical usage rather than neutral or Peninsular Spanish.
Certification and legalization
Legal instruments filed with INVIMA require an official translation by a traductor oficial recognized by the Ministerio de Relaciones Exteriores; apostille and consular legalization rules apply to foreign-origin documents.
Where submissions stall
Inconsistent INN usage, dosing rendered literally from English, and missing appendix translations trigger requerimientos and restart the review clock.
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Frequently asked
INVIMA translation, quick answers.
What language does INVIMA require for clinical trial submissions in Colombia?
INVIMA reviews dossiers in Spanish. Protocols, informed consent forms, investigator's brochures, safety narratives, and product labeling must be translated into Colombian Spanish, with source-language documents accepted only when paired with a compliant translation that preserves numbering, cross-references, and appendices.
Who is authorized to certify translations for INVIMA?
Legal instruments — powers of attorney, corporate authorizations, apostilled documents — must be translated by a traductor oficial recognized by Colombia's Ministerio de Relaciones Exteriores. Technical documents such as protocols and investigator brochures should be prepared by qualified medical translators and reviewed by clinicians familiar with Colombian regulatory usage.
How does the Amavita pilot cover INVIMA submissions?
A pilot scopes one protocol or dossier for Colombia, delivers an MD-reviewed Spanish package aligned to INVIMA expectations, and includes a pre-submission QC checklist covering terminology, formatting, and certification requirements.
Next step
Scope a Colombia pilot this quarter.
Share your Colombia protocol or registration dossier. Our team will reach out within 2 business days with a scoped pilot proposal and timeline.